Fixed-combination treatment for glaucoma, ocular hypertension deemed safe in 5-year study

J Glaucoma. 2011;20(4):215-222.

A fixed-combination of latanoprost and timolol is safe and produces no serious side effects for patients being treated for open-angle glaucoma or ocular hypertension, a study found.

The adverse event profile for the combined treatment was similar to the adverse event profile for the individual components, with 70% of subjects showing no increase in iris pigmentation after 5 years.

The open-label, phase 3b, multicenter, uncontrolled study included 974 participants who were not receptive to beta-blockers, needed additional IOP reduction and had not taken a prostaglandin in the past.

Photographs to document the appearance of the irises, eyelashes and periorbital skin were obtained at the beginning of the study and at 12 months, 36 months and 60 months after the initiation of treatment.

Increased iris pigmentation, lengthening, thickening or darkening of the eyelashes, and darkening of eyelid skin are side effects associated with prostaglandin analogues, the study authors said. Increased pigmentation occurred more frequently in study participants with mixed eye colors.

IOP lowering occurred in the first 6 months of treatment and continued throughout the 5-year period.

Being a multicenter study, there may have been differences in grading side effects and in guiding diagnosis and treatment, the investigators said.